Hatch-Waxman

Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …

The American Conference Institute’s (“ACI’s”) popular “Paragraph IV Disputes Master Symposium” is coming up again! The conference will take place from October 3-4, 2019 at the W Chicago in City Center, Chicago, IL.
ACI has put together an excellent program for conference attendees that include presentations …

The Paragraph IV certification list on FDA’s website is a very useful tool for generic drug manufacturers in evaluating the potential for 180 day exclusivity for any given product. The list generally describes drug products for which one or more substantially complete ANDA containing a paragraph …

That quote from “the Dude” from one of the final scenes of the 1998 film The Big Lebowski sums up well where things stand—or should we say “cannot stand, man”—insofar as drug pricing legislation, and, in particular, the Bringing Low-cost Options and Competition while Keeping …

As you may have noticed, FDA recently unveiled a new website. As part of this redesign, FDA “enhanced” the Product-Specific Guidances (“PSG”) for Generic Drug Development web page. The “enhanced” version of the website includes new database and search function features, export features, and paginated …

FDA’s interpretation and application of the Best Pharmaceuticals for Children Act (“BPCA”), which provides for a 6-month add-on period of pediatric exclusivity has piqued our interest more than once over the years, leading to several posts (see, e.g., here, here, and here). We now have …

As we discussed last summer, FDA has recognized that negotiations surrounding the development of a Single, Shared System REMS may fail, and, to that end, issued a guidance detailing the Agency’s waivers process. Now, the market has borne the fruits of that labor in the …

“Don’t test me!”— that’s a warning that I, along with my younger brother, Erik, heard more than once from our parents while growing up. The warning would come up from time to time—but particularly during our teenage years—when teenagers do what they sometimes do: challenge …

The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments. For several years after the enactment of Hatch-Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm. And although …

Spring is here! How do we know? Is it the cherry blossoms starting to bloom in Washington, DC? Is it the daffodils emerging from hibernation? No – we know it’s Spring because the annual American Conference Institute (“ACI”) “Paragraph IV Disputes” conference is right around …

After months of ever expanding drug recalls, and multiple investigative reports by different media outlets calling into question the safety of the U.S. generic drug supply (see, for example, “America’s Love Affair with Cheap Drugs has a Hidden Cost,” “How a Tainted Heart Drug Made …

Yeah, you know me. Given Commissioner Gottlieb’s clear proclivity for blog posts with song titles rather than Orange Book puns, we’ll stick with those for a while. We just hope the Commissioner likes early 1990s rap as much as he likes rock from the 1970s …

FDA released its annual Report to Congress on 505(q) Citizen Petitions last week – the Tenth Annual Report to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017. The Report, which is …

Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Michael Shumsky has become its newest Director. Mike joined HP&M in February 2019 after nearly 15 years at Kirkland & Ellis LLP, where he played a key role in developing that firm’s FDA and …

In yet another step to address drug pricing, Commissioner Gottlieb announced last week several new initiatives, including an update to the revered Orange Book. Cue the crazy Muppet arms! Proclaiming the Orange Book update a “transparency initiative,” FDA expects that this undertaking will “provide greater …